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| ID | Type | Description | Link |
|---|---|---|---|
| I7S-EW-HBEC | Other Identifier | Eli Lilly and Company |
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This two-part study will evaluate how safe LY3154207 is and the effects it has on the body.
Part A will include healthy participants. Each participant will receive daily doses of LY3154207 or placebo for 14 days. Part A will last approximately 4 weeks including a 17 day stay in the clinical research unit (CRU) and follow-up.
Part B is contingent on the results of Part A. Part B will include participants with Parkinson's disease. Each participant will receive daily doses of LY3154207 or placebo for 14 days. Part B will last approximately 4 weeks including a 17 day stay in the CRU and follow-up.
Both Part A and Part B will require screening within 30 days prior to the start of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3154207 | Experimental | LY3154207 administered orally once daily in multiple-ascending dose cohorts for 14 days. |
|
| Placebo | Placebo Comparator | Placebo matching LY3154207 administered once daily for 14 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3154207 | Drug | Administered orally |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | Baseline through study completion (Day 15) in each part. |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma (blood) Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3154207 | At multiple time points from baseline through day 15 in each part | |
| Plasma (blood) Pharmacokinetics: Maximum Concentration (Cmax) of LY3154207 | At multiple time points from baseline through day 15 in each part |
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Inclusion Criteria:
Part A:
Part B:
Part A and B
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parexel International LLC | Glendale | California | 91206 | United States | ||
| Compass Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34664427 | Derived | Wilbraham D, Biglan KM, Svensson KA, Tsai M, Pugh M, Ardayfio P, Kielbasa W. Safety, Tolerability, and Pharmacokinetics of Mevidalen (LY3154207), a Centrally Acting Dopamine D1 Receptor-Positive Allosteric Modulator, in Patients With Parkinson Disease. Clin Pharmacol Drug Dev. 2022 Mar;11(3):324-332. doi: 10.1002/cpdd.1039. Epub 2021 Oct 19. | |
| 33029934 |
| Label | URL |
|---|---|
| Click here for more information about this study: A Study of LY3154207 in Participants With Parkinson's Disease (Part B) | View source |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C000707472 | LY3154207 |
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| Drug |
Administered orally |
|
| Plasma (blood) Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3154207 after a High-Calorie Meal | Baseline through 24 hours after administration of study drug on Day 10 in Part A. |
| Plasma (blood) Pharmacokinetics: Maximum Concentration (Cmax) of LY3154207 after a High-Calorie Meal | Baseline through 24 hours after administration of study drug on Day 10 in Part A. |
| Orlanda |
| Florida |
| 32806 |
| United States |
| Compass Research | The Villages | Florida | 32162 | United States |
| Wilbraham D, Biglan KM, Svensson KA, Tsai M, Kielbasa W. Safety, Tolerability, and Pharmacokinetics of Mevidalen (LY3154207), a Centrally Acting Dopamine D1 Receptor-Positive Allosteric Modulator (D1PAM), in Healthy Subjects. Clin Pharmacol Drug Dev. 2021 Apr;10(4):393-403. doi: 10.1002/cpdd.874. Epub 2020 Oct 7. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |